PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy

NCT ID: NCT00943605

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-03-31

Brief Summary

The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and record operative performance, post-operative pain, drain output, and skin scarring following surgery; and to compare these endpoints to the current standard of care (SOC).

Detailed Description

Mastectomy is a surgical procedure performed to remove breast tissue that contains cancer, or has a high probability of containing cancer. During the procedure, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away the breast tissue from the chest and control bleeding. Once the breast tissue is removed the remaining skin edges are brought together with sutures.

Following mastectomy, the most common complication is persistent serous wound drainage and seroma, a collection of fluid in the closed surgical space. To help prevent this complication a tissue drain is used to remove serous fluid from the surgical space via bulb suction. The rate of serous fluid collection is used to determine the time the drain remains in place. Although suction drains help reduce seroma formation, prolonged use may delay healing, cause injury, and increase the risk of infection and patient discomfort.

The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy to enable precision cutting and coagulating at the point of application, without the thermal damage to surrounding tissues that is normally seen with traditional electrosurgery. The PlasmaBlade has received FDA clearance for use in plastic, general, and ENT surgery, and has demonstrated significantly reduced serous drainage in tissue reduction surgeries, like mastectomy.

This multi-site study was granted IRB approval and conducted between June 2009 and January 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were then required to provide informed consent prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for mastectomy with or without same day reconstruction.

Conditions

Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Group Type: ACTIVE_COMPARATOR

Scalpel and Traditional Electrosurgery

Intervention Type: DEVICE

The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.

PEAK PlasmaBlade

The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.

Group Type: EXPERIMENTAL

PEAK PlasmaBlade

Intervention Type: DEVICE

The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.

Interventions

Scalpel and Traditional Electrosurgery

The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.

Intervention Type: DEVICE

PEAK PlasmaBlade

The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 20 and 70 years old

2. Physically healthy, stable weight

3. Requiring single or bilateral simple mastectomy, with or without sentinel lymph node biopsy

4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure

5. Subject must be willing and able to comply with all follow-up evaluations

Exclusion Criteria

1. Age younger than 20 or greater than 70 years old

2. Anticoagulation therapy which cannot be discontinued

3. Prior external beam or implanted radiotherapy

4. Tobacco use (any kind)

5. Infection (local or systemic)

6. Cognitive impairment or mental illness

7. Severe cardiopulmonary deficiencies

8. Known coagulopathy

9. Immunocompromised

10. Kidney disease (any type)

11. Desiring or requiring same-day breast reconstruction

12. Prior breast reduction or augmentation surgery

13. Unable to follow instructions or complete follow-up

14. Currently taking any medication known to affect healing

15. Subjects who are status-post gastric banding or gastric bypass

16. Currently enrolled in another investigational device or drug trial

17. Time from most recent neoadjuvant therapy less than 4 weeks

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Surgical Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teresa Ponn, MD

Role: PRINCIPAL_INVESTIGATOR

Elliot Breast Health Center

Edward Dalton, MD

Role: PRINCIPAL_INVESTIGATOR

Elliot Breast Health Center

Richard Fine, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Breast Care

Peter Naruns, MD

Role: PRINCIPAL_INVESTIGATOR

Midpeninsula Surgical Associates

Saul Eisenstat, MD

Role: PRINCIPAL_INVESTIGATOR

Midpeninsula Surgical Associates

Michael Schultz, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph Medical Center

Locations

Providence St. Joseph's Medical Center

Burbank, California, United States

El Camino Hospital

Mountain View, California, United States

Advanced Breast Care

Marietta, Georgia, United States

St. Joseph Medical Center

Towson, Maryland, United States

Countries

United States

Other Identifiers

PEAK VP-00074

Identifier Type: -

Identifier Source: org_study_id